MIDAMOX FOR DOGS- imidacloprid and moxidectin solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

imidacloprid (UNII: 3BN7M937V8) (imidacloprid - UNII:3BN7M937V8), moxidectin (UNII: NGU5H31YO9) (moxidectin - UNII:NGU5H31YO9)

Available from:

Norbrook Laboratories Limited

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

Midamox for Dogs is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and the treatment of Dirofilaria immitis circulating microfilariae in heartworm-positive dogs. Midamox for Dogs kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis ). Midamox for Dogs is indicated for the treatment and control of sarcoptic mange caused by Sarcoptes scabiei var. canis. Midamox for Dogs is also indicated for the treatment and control of the following intestinal parasites: Do not administer this product orally. (See WARNINGS.) Do not use this product (containing 2.5% moxidectin) on cats.

Product summary:

Applications Per Package, 6 x 0.4 mL applicators, 6 x 1.0 mL applicators, 6 x 2.5 mL applicators, 6 x 4.0 mL applicators, 6 x 5.0 mL applicators Approved by FDA under ANADA # 200-716 Made in Ireland Manufactured by: Norbrook Manufacturing Ltd. Rossmore Industrial Estate Monaghan, Co. Monaghan Ireland Midamox® is a trademark of Norbrook Laboratories Limited Revised July 2023 224670I02

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

MIDAMOX FOR DOGS- IMIDACLOPRID AND MOXIDECTIN SOLUTION
NORBROOK LABORATORIES LIMITED
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_MIDAMOX™ FOR DOGS_
(imidacloprid + moxidectin)
_TOPICAL SOLUTION_
ONCE-A-MONTH TOPICAL SOLUTION FOR THE PREVENTION OF HEARTWORM DISEASE,
THE
TREATMENT OF CIRCULATING MICROFILARIAE, KILLS ADULT FLEAS, IS
INDICATED FOR THE
TREATMENT OF FLEA INFESTATIONS, THE TREATMENT AND CONTROL OF SARCOPTIC
MANGE, AS WELL AS THE TREATMENT AND CONTROL OF INTESTINAL PARASITE
INFECTIONS
IN DOGS AND PUPPIES THAT ARE AT LEAST 7 WEEKS OF AGE AND THAT WEIGH AT
LEAST
3 LBS.
WARNING
DO NOT ADMINISTER THIS PRODUCT ORALLY
FOR THE FIRST 30 MINUTES AFTER APPLICATION ENSURE THAT DOGS CANNOT
LICK
THE PRODUCT FROM APPLICATION SITES ON THEMSELVES OR OTHER TREATED
ANIMALS.
CHILDREN SHOULD NOT COME IN CONTACT WITH APPLICATION SITES FOR TWO (2)
HOURS AFTER APPLICATION.
(SEE CONTRAINDICATIONS, WARNINGS, HUMAN WARNINGS, AND ADVERSE
REACTIONS, FOR MORE INFORMATION)
CAUTION:
Federal (U.S.A.) Law restricts this drug to use by or on the order of
a licensed
veterinarian.
DESCRIPTION:
_Midamox for Dogs_ (10 % imidacloprid+2.5 % moxidectin) is a colorless
to yellow ready-
to-use solution packaged in single dose applicators for topical
treatment of dogs. The
formulation and dosage schedule are designed to provide a minimum of
4.5 mg/lb (10
mg/kg) imidacloprid and 1.1 mg/lb (2.5 mg/kg) moxidectin based on body
weight.
Imidacloprid is a chloronicotinyl nitroguanidine insecticide. The
chemical name for
imidacloprid is 1
-[(6-Chloro-3-pyridinyl)methyl]-N-nitro-2-imidazolidinimine.
Moxidectin is
a semisynthetic macrocyclic lactone endectocide derived from the
actinomycete
_Streptomycetes cyaneogriseus noncyanogenus._ The chemical name for
moxidectin is
[6R, 23E, 25S(E)]-5-O- Demethyl-28-de-
oxy-25-(1,3-dimethyl-1-butenyl)-6,28-epoxy-23-
(methoxyimino) milbemycin B.
INDICATIONS:
_Midamox for Dogs_ is indicated for the prevention of heartworm
disease caused by
_Dirofilaria immitis_ and the treatment of _Dirofilaria immitis_
circulating microfilariae in
heartworm-positi